Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

NCT ID: NCT04446299

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 519 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-13
• Study Completion Date: 2021-01-22

Brief Summary

The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BLI4900

Experimental bowel preparation solution for oral ingestion

Group Type: EXPERIMENTAL

Bowel Prep

Intervention Type: DRUG

Orally ingested liquid bowel preparation

FDA Approved Control

FDA approved bowel preparation solution for oral ingestion

Group Type: ACTIVE_COMPARATOR

Bowel Prep

Intervention Type: DRUG

Orally ingested liquid bowel preparation

Interventions

Bowel Prep

Orally ingested liquid bowel preparation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
• 18 to 85 years of age (inclusive)
• If female, and of child-bearing potential, is using an acceptable form of birth control.
• Negative serum pregnancy test at screening, if applicable
• In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria

• Subjects with known or suspected ileus, gastrointestinal obstruction, gastroparesis, gastric retention, bowel perforation, toxic colitis or megacolon.
• Subjects with inflammatory bowel disease who have a history of any bowel resection (small intestine or colon), suspected active inflammation, or symptoms suggestive of obstruction or known bowel stricture.
• Subjects who had previous significant gastrointestinal surgeries.
• Subjects who have regularly used laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation
• Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
• Subjects taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days.
• Subjects with uncontrolled hypertension.
• Subjects taking antibiotics within 7 days of colonoscopy.
• Subjects with severe renal, hepatic or cardiac insufficiency.
• Subjects with an abnormal and clinically significant physical examination or ECG finding at Visit 1.
• Subjects undergoing insulin therapy for any indication.
• Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
• Subjects undergoing colonoscopy for foreign body removal and/or decompression.
• Subjects taking tricyclic antidepressants.
• Subjects using drugs of abuse, including abused prescription medications.
• Subjects who are withdrawing from alcohol or benzodiazepines.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John McGowan

Role: STUDY_DIRECTOR

Braintree Laboratories / Sebela Pharmaceuticals

Locations

301 Research Site 18

Huntsville, Alabama, United States

301 Research Site 24

Sun City, Arizona, United States

301 Research Site 7

San Diego, California, United States

301 Research Site 16

Clearwater, Florida, United States

301 Research Site 12

Jacksonville, Florida, United States

301 Research Site 9

Palm Harbor, Florida, United States

301 Research Site 4

Palmetto Bay, Florida, United States

301 Research Site 26

Port Orange, Florida, United States

301 Research Site 14

St. Petersburg, Florida, United States

301 Research Site 25

Sunrise, Florida, United States

301 Research Site 2

Decatur, Georgia, United States

301 Research Site 10

Indianapolis, Indiana, United States

301 Research Site 3

Monroe, Louisiana, United States

301 Research Site 17

Shreveport, Louisiana, United States

301 Research Site 11

Flowood, Mississippi, United States

301 Research Site 13

Chesterfield, Missouri, United States

301 Research Site 19

Reno, Nevada, United States

301 Research Site 15

Brooklyn, New York, United States

301 Research Site 5

Great Neck, New York, United States

301 Research Site 23

New York, New York, United States

301 Research Site 6

Raleigh, North Carolina, United States

301 Research Site 21

Mentor, Ohio, United States

301 Research Site 20

Hixson, Tennessee, United States

301 Research Site 1

Ogden, Utah, United States

301 Research Site 22

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BLI4900-301

Identifier Type: -

Identifier Source: org_study_id